you say you agree that at “some stage” “we” will need to do RCT...

you say you agree that at “some stage” “we” will need to do RCT in US. You speaking on behalf of the company? If so that’s pretty worrying as it suggests Osl in no hurry to do it. The point of fda breakthrough classification that was granted over a year ago is to help companies with study design and speed things up isn’t that right? . So has Osl taken advantage of this yet or not?
the point of the RCT is not to mimic Panco. The point is to prove in a statistically and scientifically valid way that ,depending on what you compare with, either the device conclusively provides benefit above chemo or that it conclusively shows it’s better than standard radiation treatment. You might think or belief it does but that’s not the same thing as proving it does!